BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRISMAFLEX

    MDR report key: 1938912 · Received November 25, 2010

    Report

    Report Number
    9616026-2010-00014
    Event Type
    Injury
    Date Received
    November 25, 2010
    Date of Event
    October 29, 2010
    Report Date
    October 29, 2010
    Manufacturer
    GAMBRO LUNDIA AB
    Product Code
    KDI
    PMA / PMN Number
    K072093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GAMBRO TECHNICAL SERVICE REP INSPECTED THE PRISMAFLEX MACHINE. HE COULD NOT REPRODUCE THE PROBLEMS REPORTED AND FOUND THE PRISMAFLEX TO BE OPERATING ACCORDING TO THE MANUFACTURER'S SPECIFICATION. THE PRISMAFLEX WAS RETURNED TO SERVICE. IF AN ALARM OCCURS WHILE THE SCREEN IS FROZEN, THE SAFETY SYSTEMS WILL SET THE MACHINE IN PT SAFE STATE. IN THE LATER PRISMAFLEX SOFTWARE VERSIONS SW VERSION 4.00/5.10, IMPROVEMENTS WERE MADE TO ADDRESS THE CAUSE OF THE FROZEN SCREEN. THE SOFTWARE VERSION 4.00/5.10 IS PENDING FDA APPROVAL, K083775, (B)(4).

    Description of Event or Problem · 1

    WHILE THE PT WAS RECEIVING UNEVENTFUL CONTINUOUS VENOVENOUS HEMOFILTRATION SINCE (B)(6) 2010, OVER THE COURSE OF TWO MINS, THE PRISMAFLEX EXHIBITED MULTIPLE CONSECUTIVE ALARMS. THE MACHINE WAS POWERED OFF FOR TWO MINS AND THEN POWERED BACK ON. WHEN THE NURSE POWERED THE PRISMAFLEX BACK ON, "BLOOD DETECTED IN SET" AND "AIR IN BLOOD" ALARMS WERE GENERATED. AT THIS POINT THE NURSE WAS UNABLE TO CONTINUE. THE SCREEN DID NOT RESPOND AND THE NURSE REPORTED "THE SCREEN WAS FROZEN". THE NURSE ELECTED NOT TO MANUALLY RETURN THE BLOOD IN THE CIRCUIT, RESULTING IN AN APPROXIMATE 165 ML BLOOD LOSS. THE PT'S HEMODYNAMIC STATUS WAS DESCRIBED AS UNCHANGED. THE PT WAS TRANSFUSED THREE UNITS OF RBC - LEUKOCYTES REDUCED IRRADIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMAFLEX KDI GAMBRO LUNDIA AB 107493

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention PRISMASOL BGK2/0 WITH 10 MEQ KCL ADDED: LOT # UNK| PRISMAFLEX HF1000 FILTER SET: LOT NUMBER UNKNOWN